by Dr. Yashashwini Reddy | Sep 19, 2024
Japan Regulatory Authorities for Drug Approval: A Comprehensive Overview Navigating the complex landscape of drug approval in Japan requires a keen understanding of its regulatory authorities and processes. Japan’s commitment to ensuring the safety and efficacy...
by Dr. Yashashwini Reddy | Sep 19, 2024
The Sakigake Designation is an innovative program by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), designed to fast-track the development and approval of breakthrough medical products. “Sakigake” translates to “forerunner” or...
by Dr. Yashashwini Reddy | Sep 19, 2024
Japan’s new drug approval process is managed by the Pharmaceuticals and Medical Devices Agency (PMDA), which works under the Ministry of Health, Labour, and Welfare (MHLW). Here’s an overview of how a drug gets approved in Japan: 1. Preclinical Testing...
by Dr. Yashashwini Reddy | Jun 15, 2024
In this article, we are going to see the timelines and regulatory pathways for medical devices, Small molecules drugs, etc. Regulatory pathways for New Chemical entities: Small molecules drugs are chemically synthesized ones i.e. new molecules – Traditional NDA...
by Dr. Yashashwini Reddy | Jun 15, 2024
Navigating the Premarket Notification (510(k)) Process Premarket notification is a regulatory pathway for getting the FDA’s clearance of medical device marketing in the US. A 510(k) is a premarket submission made to the FDA to provide evidence that the medical...
